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Rotavirus vaccine

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Rotavirus vaccine
Vaccine description
TargetRotavirus
Vaccine typeAttenuated
Clinical data
Trade namesRotarix, Rotateq, others
AHFS/Drugs.comMonograph
MedlinePlusa607024
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
KEGG
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The rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children.[6] The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea.[6] Immunizing babies decreases rates of disease among older people and those who have not been immunized.[7]

The World Health Organization (WHO) recommends that rotavirus vaccine be included in national routine vaccinations programs, especially in areas where the disease is common.[6] This should be done along with promoting breastfeeding, handwashing, clean water, and good sanitation.[6] It is given by mouth and requires two or three doses.[6] The vaccines are safe.[6] This includes their use in people with HIV/AIDS.[6] The vaccines are made from weakened rotavirus.[6]

The vaccine first became available in the United States in 2006.[8] It is on the World Health Organization's List of Essential Medicines.[9] The vaccine is available in many countries.[6]

Medical uses

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Effectiveness

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Safety and efficacy trials in Africa and Asia found that the vaccines dramatically reduced severe disease among infants in developing countries, where a majority of rotavirus-related deaths occur.[10][11] A 2021 Cochrane systematic review concluded that Rotavac, Rotateq, and Rotarix vaccines are safe and are effective at preventing diarrhea that is related to a rotavirus infection.[12]

Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination.[13] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.[14] In Mexico, which in 2006 was among the first countries in the world to introduce rotavirus vaccine, the diarrheal disease death rates from rotavirus dropped by more than 65% among children age two and under during the 2009 rotavirus season.[15] In Nicaragua, which in 2006 became the first developing country to introduce the rotavirus vaccine, investigators recorded a substantial impact, with rotavirus vaccine preventing 60% of cases against severe rotavirus and cutting emergency room visits in half.[16] In the United States, vaccination has reduced rotavirus-related hospitalizations by as much as 86% since 2006. In April 2016, the World Health Organization released statistics for the period of 2000–2013, which showed developing countries that have introduced rotavirus vaccines experienced significant decreases in deaths and hospitalizations from rotavirus diarrhea after introduction.[17][11]

Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections.[7] A 2014 review of available clinical trial data from countries routinely using rotavirus vaccines in their national immunization programs found that rotavirus vaccines have reduced rotavirus hospitalizations by 49–92% and all-cause diarrhea hospitalizations by 17–55%.[18]

Schedule

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The World Health Organization recommends the first dose of vaccine be given right after six weeks of age.[6]

Types

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Rotarix

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Rotarix vaccine for oral administration

Rotarix is a monovalent, human, live attenuated rotavirus vaccine containing one rotavirus strain of G1P[8] specificity. Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.[19] It was approved in the European Union in 2006, and by the US FDA in April 2008.[20][21] It is taken by mouth.[22][23]

Rotateq

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Rotateq is a live, oral pentavalent vaccine that contains five rotavirus strains produced by reassortment.[medical citation needed] The rotavirus A parent strains of the reassortants were isolated from human and bovine hosts.[medical citation needed] Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein VP4 (type P7) from the bovine rotavirus parent strain.[medical citation needed] The fifth reassortant virus expresses the attachment protein VP4, (type P1A), from the human rotavirus parent strain and the outer capsid protein VP7 (serotype G6) from the bovine rotavirus parent strain.[medical citation needed] In February 2006, the US Food and Drug Administration (FDA) approved Rotateq for use in the United States.[24][25] In August 2006, Health Canada approved Rotateq for use in Canada.[26] Merck worked with a range of partners including governmental and non-governmental organisations to develop and implement mechanisms for providing access to this vaccine in the developing world,[27] an effort which was slated to come to an end in 2020.[28]

Rotavac

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Rotavac was licensed for use in India in 2014, and is manufactured by Bharat Biotech International Limited. It is a live attenuated, monovalent vaccine containing a G9P[11] human strain isolated from an Indian child.[29] It is given by mouth in a three-dose series, four weeks apart, beginning at six weeks of age up until eight months of age.[30]

Rotavin-M1

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Rotavin-M1 was licensed for use in Vietnam in 2007, and is manufactured by the Center for Research and Production of Vaccines. The vaccine contains a G1P[8] human rotavirus strain.[31]

Lanzhou lamb

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Lanzhou lamb rotavirus vaccine was licensed for use in China in 2000, and is manufactured by the Lanzhou Institute of Biological Products. It contains a G10P[12] lamb rotavirus strain.[31]

Rotasiil

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Rotasiil is a lyophilized pentavalent vaccine licensed for use in India in 2018. It contain human bovine reassortant strains of rotavirus serotypes G1, G2, G3, G4 and G9. This is world's first thermostable vaccine which can be stored without refrigeration at or below 25 °C. Rotasiil is manufactured by the Serum Institute of India.[32][33]

History

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In 1998, a rotavirus vaccine (RotaShield, by Wyeth) was licensed for use in the United States. Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe diarrhea caused by rotavirus A, and researchers had detected no statistically significant serious adverse effects. However post-licensure studies conducted in the United States by Trudy Murphy and her colleagues at the Centers For Disease Control and Prevention (CDC) and Kramarz et al., found that Infants who received the vaccine were 30 times more likely to develop a severe form of bowel obstruction, called intussusception, during 3 to 7 days after the first dose than unvaccinated infants.[34][35] The excess risk was estimated between one case in 5,000 to 10,000 vaccinees. Based on these data, the Advisory Committee on Immunization Practices (ACIP) withdraw recommendation to use the vaccine,[36] and the manufacturer of the vaccine withdrew it from the market in 1999. There then followed eight years of delay until rival manufacturers were able to introduce new vaccines that were shown to be more safe and effective in children: Rotarix by GlaxoSmithKline[19] and Rotateq by Merck.[37] Both are taken orally and contain disabled live virus.[8]

The World Health Organization recommends that rotavirus vaccine be included in all national immunization schedules because the risk of intussusception following rotavirus vaccination remains very low compared with the benefits of preventing the impact of severe and deadly diarrhoea.[38]

Society and culture

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Economics

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A 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide. At US$5 per dose, the estimated cost per life saved was $3,015, $9,951 and $11,296 in low-, lower-middle-, and upper-middle-income countries, respectively.[39]

More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of Gavi, the Vaccine Alliance.[31]

Temporary suspension in the US

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In March 2010, the detection of DNA from porcine circovirus types 1 and 2 within Rotateq and Rotarix prompted the FDA to suspend the use of rotavirus vaccines while conducting an investigation the finding of DNA from porcine circovirus-1 (PCV1) in the vaccine in collaboration with the 12 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).[40] On 6 May 2010, the FDA announced its decision to revoke the suspension, stating that porcine circovirus types 1 and 2 pose no safety risks in humans and concluded that health risks involved did not offset the benefits of the vaccination.[40] In May 2010 the suspension of the Rotarix vaccine was lifted.[41]

Research

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Doctors Without Borders (MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials were completed in Niger on 31 December 2020.[42][43]

The vaccine has been associated with lower rates of type 1 diabetes.[44][45]

References

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  1. ^ "Rotarix- rotavirus vaccine, live, oral kit; Rotarix- rotavirus vaccine, live, oral solution". DailyMed. 24 January 2024. Archived from the original on 1 December 2023. Retrieved 27 May 2024.
  2. ^ "Rotateq- rotavirus vaccine, live, oral, pentavalent solution". DailyMed. 7 March 2023. Archived from the original on 12 September 2023. Retrieved 27 May 2024.
  3. ^ "Rotarix EPAR". European Medicines Agency (EMA). 21 February 2006. Archived from the original on 1 December 2023. Retrieved 27 May 2024.
  4. ^ "Rotateq". European Medicines Agency (EMA). 27 June 2006. Archived from the original on 2 May 2024. Retrieved 27 May 2024.
  5. ^ "Rotashield EPAR". European Medicines Agency (EMA). 7 June 2001. Archived from the original on 1 October 2022. Retrieved 27 May 2024.
  6. ^ a b c d e f g h i j "Rotavirus vaccines. WHO position paper – January 2013". Relevé Épidémiologique Hebdomadaire. 88 (5): 49–64. February 2013. hdl:10665/242024. PMID 23424730.
  7. ^ a b Patel MM, Steele D, Gentsch JR, Wecker J, Glass RI, Parashar UD (January 2011). "Real-world impact of rotavirus vaccination". The Pediatric Infectious Disease Journal. 30 (1 Suppl): S1–S5. doi:10.1097/INF.0b013e3181fefa1f. PMID 21183833. S2CID 1893099.
  8. ^ a b "Rotavirus Vaccine Live Oral". The American Society of Health-System Pharmacists. Archived from the original on 22 December 2015. Retrieved 14 December 2015.
  9. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
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  11. ^ a b Parashar UD, Johnson H, Steele AD, Tate JE (May 2016). Parashar UD, Tate JE (eds.). "Health Impact of Rotavirus Vaccination in Developing Countries: Progress and Way Forward". Clinical Infectious Diseases. 62 (Suppl 2): S91–S95. doi:10.1093/cid/civ1015. PMC 11343039. PMID 27059361.
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  16. ^ Patel M, Pedreira C, De Oliveira LH, Tate J, Orozco M, Mercado J, et al. (June 2009). "Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua". JAMA. 301 (21): 2243–2251. doi:10.1001/jama.2009.756. PMID 19491186.
  17. ^ "WHO | Estimated rotavirus deaths for children under 5 years of age: 2013, 215 000". WHO. Archived from the original on 2 April 2014. Retrieved 30 March 2021.
  18. ^ Tate JE, Parashar UD (November 2014). "Rotavirus vaccines in routine use". Clinical Infectious Diseases. 59 (9): 1291–1301. doi:10.1093/cid/ciu564. PMID 25048849.
  19. ^ a b O'Ryan M (February 2007). "Rotarix (RIX4414): an oral human rotavirus vaccine". Expert Review of Vaccines. 6 (1): 11–19. doi:10.1586/14760584.6.1.11. PMID 17280473. S2CID 40193617.
  20. ^ "Rotarix". U.S. Food and Drug Administration (FDA). 4 November 2022. Archived from the original on 14 February 2024. Retrieved 27 May 2024.
  21. ^ "Rotarix". U.S. Food and Drug Administration (FDA). 13 April 2009. Archived from the original on 22 July 2017. Retrieved 27 May 2024.
  22. ^ "Approval Letter—Rotarix". U.S. Food and Drug Administration. 3 April 2008. Archived from the original on 29 November 2014.
  23. ^ Clark HF, Offit PA, Parashar UD (2013). "30. Rotavirus Vaccines". In Plotkin SA, Orenstein WA, Offit PA (eds.). Vaccines. Elsevier Saunders. pp. 669–687. ISBN 978-1-4557-0090-5.
  24. ^ "Rotateq". U.S. Food and Drug Administration (FDA). 14 August 2020. Archived from the original on 17 May 2024. Retrieved 27 May 2024.
  25. ^ "Rotateq". U.S. Food and Drug Administration (FDA). 25 February 2009. Archived from the original on 22 July 2017. Retrieved 27 May 2024.
  26. ^ "Rotateq Is Approved In Canada" (PDF) (Press release). Merck Frosst Canada. 23 August 2006. Archived from the original (PDF) on 2 October 2008. Retrieved 29 February 2008.
  27. ^ McCarthy M (February 2003). "Project seeks to "fast track" rotavirus vaccine". Lancet. 361 (9357): 582. doi:10.1016/S0140-6736(03)12549-4. PMID 12598149. S2CID 5347100. Archived from the original on 29 August 2021. Retrieved 2 November 2018.
  28. ^ "Merck Ends Delivery of Lifesaving Vaccines to Africa". The Presidential Daily Brief: Intriguing. OZY. Ozymandias.com. 2 November 2018. Archived from the original on 2 November 2018. Retrieved 2 November 2018.
  29. ^ World Health Organization (2014). "Global Advisory Committee on Vaccine Safety, 11-12 June 2014". Weekly Epidemiological Record. 89 (29): 321–36. hdl:10665/242243.
  30. ^ "ROTAVAC—Bharat Biotech". Archived from the original on 7 June 2019. Retrieved 29 October 2019.
  31. ^ a b c Rota Council (2016). Rotavirus: Common, Severe, Devastating, Preventable (PDF). Archived (PDF) from the original on 8 September 2017.
  32. ^ "ROTASIIL". WHO—Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 17 July 2020. Archived from the original on 27 July 2022. Retrieved 30 March 2021.
  33. ^ Naik SP, Zade JK, Sabale RN, Pisal SS, Menon R, Bankar SG, et al. (May 2017). "Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®)". Vaccine. 35 (22): 2962–2969. doi:10.1016/j.vaccine.2017.04.025. PMID 28434688.
  34. ^ Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, et al. (February 2001). "Intussusception among infants given an oral rotavirus vaccine". The New England Journal of Medicine. 344 (8): 564–572. doi:10.1056/NEJM200102223440804. PMID 11207352.
  35. ^ Kramarz P, France EK, Destefano F, Black SB, Shinefield H, Ward JI, et al. (April 2001). "Population-based study of rotavirus vaccination and intussusception". The Pediatric Infectious Disease Journal. 20 (4): 410–416. doi:10.1097/00006454-200104000-00008. PMID 11332666. S2CID 23664999.
  36. ^ Centers for Disease Control and Prevention (CDC) (September 2004). "Suspension of rotavirus vaccine after reports of intussusception--United States, 1999". MMWR. Morbidity and Mortality Weekly Report. 53 (34): 786–789. PMID 15343145.
  37. ^ Matson DO (October 2006). "The pentavalent rotavirus vaccine, Rotateq". Seminars in Pediatric Infectious Diseases. 17 (4): 195–199. doi:10.1053/j.spid.2006.08.005. PMID 17055370.
  38. ^ "Global Advisory Committee on Vaccine Safety, 11–12 December 2013". Relevé Épidémiologique Hebdomadaire. 89 (7): 53–60. February 2014. hdl:10665/242177. PMID 24707510.
  39. ^ Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD (November 2009). "Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries". The Journal of Infectious Diseases. 200 (Suppl 1): S16–S27. doi:10.1086/605026. PMID 19817595.
  40. ^ a b U.S. Food and Drug Administration. "Update on Recommendations for the Use of Rotavirus Vaccines". Food and Drug Administration. Archived from the original on 19 June 2012. Retrieved 13 July 2012.
  41. ^ "Rotarix Vaccine Suspension Lifted". FDA's MedWatch Safety Alerts. May 2010. Archived from the original on 24 August 2010.
  42. ^ Clinical trial number Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger NCT02145000\Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger at ClinicalTrials.gov
  43. ^ Hodal K (22 March 2017). "Rotavirus vaccine could save lives of almost 500,000 children a year". The Guardian. ISSN 0261-3077. Archived from the original on 23 March 2017. Retrieved 24 March 2017.
  44. ^ "Rotavirus vaccination tied to lower rates of type 1 diabetes". Reuters. 22 January 2019. Archived from the original on 10 February 2019. Retrieved 10 February 2019.
  45. ^ Bakalar N (30 January 2019). "Rotavirus Vaccine May Protect Against Type 1 Diabetes". The New York Times. ISSN 0362-4331. Archived from the original on 12 February 2019. Retrieved 10 February 2019.

Further reading

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